GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice
Introduction: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examini...
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| Format: | Journal Article |
| Language: | English |
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2018
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| Online Access: | https://hdl.handle.net/10356/88150 http://hdl.handle.net/10220/45644 |
| _version_ | 1824454666544480256 |
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| author | Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James |
| author2 | Lee Kong Chian School of Medicine (LKCMedicine) |
| author_facet | Lee Kong Chian School of Medicine (LKCMedicine) Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James |
| author_sort | Furler, John |
| collection | NTU |
| description | Introduction: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP). Methods and analysis: General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking ‘does intermittent r-CGM in adults with T2D in primary care improve HbA1c?’ Primary outcome: Absolute difference in mean HbA1c at 12 months follow-up between intervention and control arms. Secondary outcomes: (a) r-CGM per cent time in target (4–10 mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes). Eligibility: Aged 18–80 years, T2D for ≥1 year, a (past month) HbA1c>5.5 mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four months). Our general glycaemic target is 53 mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64 mmol/mol (8%)). Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1 hour education by a specialist diabetes nurse. The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5 mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition). |
| first_indexed | 2025-02-19T03:25:56Z |
| format | Journal Article |
| id | ntu-10356/88150 |
| institution | Nanyang Technological University |
| language | English |
| last_indexed | 2025-02-19T03:25:56Z |
| publishDate | 2018 |
| record_format | dspace |
| spelling | ntu-10356/881502020-11-01T05:30:48Z GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James Lee Kong Chian School of Medicine (LKCMedicine) Clinical Trials DRNTU::Science::Medicine Primary Care Introduction: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP). Methods and analysis: General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking ‘does intermittent r-CGM in adults with T2D in primary care improve HbA1c?’ Primary outcome: Absolute difference in mean HbA1c at 12 months follow-up between intervention and control arms. Secondary outcomes: (a) r-CGM per cent time in target (4–10 mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes). Eligibility: Aged 18–80 years, T2D for ≥1 year, a (past month) HbA1c>5.5 mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four months). Our general glycaemic target is 53 mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64 mmol/mol (8%)). Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1 hour education by a specialist diabetes nurse. The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5 mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition). NMRC (Natl Medical Research Council, S’pore) Published version 2018-08-23T04:26:32Z 2019-12-06T16:57:09Z 2018-08-23T04:26:32Z 2019-12-06T16:57:09Z 2018 Journal Article Furler, J., O’Neal, D. N., Speight, J., Blackberry, I., Manski-Nankervis, J.-A., Thuraisingam, S., . . . Best, J. (2018). GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice. BMJ Open, 8(7), e021435-. doi:10.1136/bmjopen-2017-021435 https://hdl.handle.net/10356/88150 http://hdl.handle.net/10220/45644 10.1136/bmjopen-2017-021435 en BMJ Open © 2018 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. 10 p. application/pdf |
| spellingShingle | Clinical Trials DRNTU::Science::Medicine Primary Care Furler, John O’Neal, David Norman Speight, Jane Blackberry, Irene Manski-Nankervis, Jo-Anne Thuraisingam, Sharmala de La Rue, Katie Ginnivan, Louise Browne, Jessica Lea Holmes-Truscott, Elizabeth Khunti, Kamlesh Dalziel, Kim Chiang, Jason Audehm, Ralph Kennedy, Mark Clark, Malcolm Jenkins, Alicia Josephine Liew, Danny Clarke, Philip Best, James GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
| title | GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
| title_full | GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
| title_fullStr | GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
| title_full_unstemmed | GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
| title_short | GP-OSMOTIC trial protocol : an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice |
| title_sort | gp osmotic trial protocol an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring r cgm on hba1c in adults with type 2 diabetes in general practice |
| topic | Clinical Trials DRNTU::Science::Medicine Primary Care |
| url | https://hdl.handle.net/10356/88150 http://hdl.handle.net/10220/45644 |
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